Siemens Biograph 16 TruePoint PET/CT Scanners Recalled for Calibration Error
Siemens is recalling 63 Biograph 16 TruePoint PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a potential calibration error leading to unexpected values, with no reported injuries or illnesses in the source text.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling 63 units of the Biograph 16 TruePoint combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners. The affected units are identified by specific serial numbers listed in the recall notice and were distributed worldwide and nationwide in the US.
The recall was initiated because Siemens Medical Solutions, Molecular Imaging became aware of a potential for unexpected Standardized Uptake Value (SUV) values if a non-Siemens phantom is used for calibration. The product is a medical imaging device that provides registration and fusion of high-resolution physiologic and anatomic information.
Healthcare facilities and users of these devices should contact Siemens Medical Solutions USA Inc. for further instructions on how to address the calibration issue. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Affected units
- 63
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers: 72402
- 72404
- 72407
- 72414
- 72419
- 72420
- 72421
- 72427
- 72429
- 72431
- 72433
- 72434
- 72435
- 72436
- 72437
- 72440
- 72441
- 72443
- 72444
- 72445
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 33 recalled by Siemens Medical Solutions USA Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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